Pharmaceutical Scientist-Clinical Lab Manager

Posted on: 2006-01-05

Steven G. Matthes 1414 Crystal Lake Cir E, Pearland, TX 77584 [email protected] Work 713-792-4450 Home 281-412-2180 Pharmaceutical Scientist-Comprehensive Overview Recognized leader in the Pharmacokinetics and Pharmacology of Oncology API\\\'s with over 40 publications. 20 years of experience utilizing comprehensive \\\"hands on\\\" knowledge of analytical chemistry, methods and process development, in vivo pharmacology and regulatory affairs. •Bench level developer of multiple CAP-cGLP-cGMP-FDA approved methods, products, processes and SOP’s. •Certified Clinical Lab Manager with 20 years hands on experience in high complexity testing, project management, strategic planning, personnel, regulatory affairs and million dollar budgets. •Gloves on in vivo pharmacologist-toxicologist with over 2500 rodent survival surgeries performed. Authored AAALAC-IACUC approved protocols. Executed studies in ADMET, metabolite determination, structure proofing, organ injury modeling, micro-vascular surgery and formulary development. • Personally developed pharmacokinetic, bioavailablity, bioequivalence and pharmacodynamic models and processed over 5000 \\\"real time\\\" PK profiles for multiple API\\\'s using Winnonlin in both animals and humans. Human data applied for dose adjustment in multisite Phase I-IV trials. •Created million dollar revenues through project management and strategic planning. Managed scientific staff of 25 in 24/7 multidisciplinary-multisite lab operations. Simultaneously managed clinical, in vivo pharmacology, analytical sciences and process development teams. •Experienced IT Professional with expertise in Windows-based environments, networking, Access database design, software validations and LIMs interfaces in accordance with 21 CFR 11. •Technical writing experience with NDA’s, clinical study data analysis, clinical study documentation reports, brochures and FDA reports. Education •Duke University honors graduate with triple majors in Biology, Chemistry and German. •Recipient of multiple chemical/pharmaceutical industry sponsored scholarships. Worked to finance last 2 years. Selected Achievements and Skills •Project management experience founding start-up labs, raw material scale-ups and multidisciplinary clinical trials. •Developed and validated analytical methods using HPLC, LC-MS, GC, GC-MS, AA, NMR, UV, ELISA, SDS etc. •Formulated API\\\'s for IND\\\'s, molecular standards for nationwide QA-QC reference testing and humanized monoclonal radiopharmaceuticals according to cGMP-cGLP, NCCLS and FDA guidelines. •Implemented cost containment programs focused on equipment maintenance, training, vendor negotiations, robotics, bar coding and automation. •Award winning Medical Technologist with generalist background and CLIAA accredited Supervisory rating with experience successfully managing large staffs in 24/7 operations of CAP-JCAHO laboratories. •Documented leadership skills and exemplary evaluations ranked in top 5% at major institutions. •Collaborated with the Cancer Informatics Director at CU in the development and maintenance of BMT LIS systems and interfaces. Interfaces maintained included HL7 based ADT and Cerner labs. Systems maintained, Pharmacology System and BMT TMR medical records system. Career Overview MD Anderson Cancer Center – Scientist-Lab Manager 2002-Present University of Colorado Hospital - Scientist-Lab Manager 1990-2002 Duke University - Chief Technologist 1982 - 1985 and 1987 - 1990 Roche Biomedical - Supervisor Toxicology/GC/GC-MS 1985 - 1987 Marshalton Research Labs - Production/QA Manager 1981 – 1982 Affiliations and Licenses QA-QC Committee, University of Colorado Hospital, Denver, CO, 1990 to 2002 American Chemical Society- Colorado Section American Medical Technologists, Park Ridge, IL. License 533234, 1988 to 2005 USGA, 9 Handicap, 1995 to 2005 Trout Unlimited, Benefactor, Volunteer, 1995 to 2005 Sample Workshops Pharmacokinetic Modeling Workshop-Sponsored by ClinTrials Inc.- 1992 Intermediate Microsoft Access-Application Developers Training Company-1995 Workshop in Basic Pharmacokinetics-University of Manchester School of Pharmacy-1997 Principles of ICH GCP- University of Colorado Health Sciences Center- 1998 Intermediate PK/PD Modeling Methodology-Pharsight Corporation-2002 Clinical Research Training Program-MD Anderson Cancer Center-2005 Publications Book Chapters: 1. Jones RB, Matthes S: Pharmacokinetics. In: Armitage and Antman High Dose Cancer Therapy, pp. 43-61, 1991 2. Jones RB, Matthes S, Dufton C, Bearman SI, Stemmer SM, Myers S, Shpall EJ. The pharmacology of intensive cyclophosphamide, cisplatin, and BCNU (CPA/cDDP/BCNU) in patients with breast cancer. In Dick KA and Keating A (eds): Proceedings of 6th International Autologous Bone Marrow Transplant Symposium, Cancer Treatment Research Education Fund, Arlington, pp 124-8, 1993. 3. Jones RB, Matthes S, Dufton C: Pharmacokinetics. In: Armitage JO, Antman KH Eds. High-Dose Cancer Therapy: Pharmacology, Hematopoietins, Stem Cells; Second Edition. Williams & Wilkins, pp 49-68, 1995. 4. Jones RB, Matthes S, Dufton C, Shpall EJ, Bearman SI, Ross M, Cagnoni PJ. Nitrosoureas. A Clinicians Guide to Chemotherapy Pharmacokinetics and Pharmacodynamics. Grochow, L. and Ames, M. Eds. Williams & Wilkins, pp 331-345, 1998. Journal Articles: 1. Jones RB, Matthes S, Shpall EJ, Fisher JH, Stemmer SM, Dufton C, et al. Acute lung injury following treatment with high-dose cyclophosphamide, Cisplatin, and carmustine: Pharmacodynamic evaluation of carmustine. J. Natl. Cancer Institute 85(8): 640-647, 1993. 2. Jones RB, Matthes S, Dufton C, et al. Pharmacokinetic/Pharmacodynamic interactions of intensive cyclophosphamide, Cisplatin, and BCNU in patients with breast cancer. Breast Cancer Res. Treat. 26 Suppl: S11-17, 1993. 3. Jones RB, Matthes S, Dufton C, et al. The Pharmacology of Intensive Cyclophosphamide, Cisplatin, and BCNU (CPA/cDDP/BCNU) in Patients with Breast Cancer. Proceedings of 6th International Autologous Bone Marrow Transplant Symposium, Eds. Dicke KA, Keating A. Cancer Treatment Research Education Fund, Arlington, Texas, pp 124-128, 1993. 4. Jones RB, Matthes S, Kemme D, Dufton C, Kernan S. Cyclophosphamide, cisplatin, and carmustine: pharmacokinetics of carmustine following multiple alkylating-agent interactions. Cancer Chemotherapy. & Pharmacol 35(1): 59-63, 1994. 5. Cagnoni PJ, Matthes S, Dufton C, et al. Ondansetron significantly reduces the area under the curve (AUC) of Cyclophosphamide (CPA) and cisplatin (CDDP). Proc Amer Soc Clin Oncol 14:A1489, 1995. 6. Schrier DM, Stemmer S, Johnson T, Kasliwal R, Lear J, Matthes S, et al. High-dose 90Y Mx-DTPA-BrE-3 and autologous hematopoietic stem cell support (AHSCS) for the treatment of advanced breast cancer. A phase I trial. Cancer Research 55 (23):5921S-24S, 1995. 7. Stemmer SM, Cagnoni PJ, Shpall EJ, Bearman SI, Matthes S, Dufton C, et al. High-dose paclitaxel, cyclophosphamide, and cisplatin with autologous hematopoietic progenitor-cell support: A phase I trial. J. Clin. Oncol.14: (5) 1463-1472, 1996. 8. Cagnoni PJ, Shpall EJ, Bearman SI, Matthes S, et al. Placitaxel-containing high-dose chemotherapy: The University of Colorado Experience. Sem in Oncol 23(6):15 43-48, 1996. 9. Cagnoni PJ, Nieto Y, Shpall EJ, Bearman SI, Barón AE, Ross M, Matthes S, et al: High-dose chemotherapy with autologous hematopoietic progenitor cell support as part of combined modality therapy in patients with inflammatory breast cancer. J Clin Oncol 16 (5):1661-8, 1998. 10. Nieto Y, Cagnoni PJ, Shpall EJ, Matthes S, et al. Prospective phase II study of high-dose chemotherapy with autologous stem cell transplant for patients with stage IV breast cancer with minimal metastatic disease. Clin Cancer Res 5: 1731-1737, 1999. 11. Nieto Y, Xu X, Cagnoni PJ, Matthes S, et al. Non-predictable pharmacokinetic behavior of cyclophosphamide when combined at high doses with cisplatin and BCNU. Clin Cancer Res 5:747-51, 1999. 12. Cagnoni PJ, Matthes S, et al. Modification of the pharmacokinetics of high-dose cyclophosphamide and cisplatin by antiemetics. Bone Marrow Transplant 1999, 24:1-4. 13. Nieto Y, Cagnoni PJ, Bearman SI, Shpall EJ, Matthes S, et al. Acute encephalopathy: A new toxicity associated with high-dose paclitaxel. Clinical Cancer Research 5: 501-506, 1999. Editorial about this article by E Rowinsky in Clinical Cancer Research 5: 481-486, 1999. 14. Nieto Y, Cagnoni PJ, Bearman SI, Shpall EJ, Matthes S, Jones RB. Cardiac toxicity following high-dose cyclophosphamide, cisplatin, and BCNU (STAMP-I) in breast cancer patients. Biology of Blood and Marrow Transplantation 6: 198-203, 2000. 15. Nieto Y, Nawaz S, Jones RB, Shpall EJ, Cagnoni PJ, McSweeney PA, Baron A, Razook C, Matthes S, Bearman SI. Prognostic Model for Relapse after High-Dose Chemotherapy with Autologous Stem-Cell Transplantation for Stage IV Oligometastatic Breast Cancer. J Clin Oncol 2002 20(3):707-718, 2002 16. Jones RB, Stockerl-Goldstein KE, Klein J, Murphy J, Blume KG, Dansey R, Martinez C, Matthes S, Nieto Y. A Randomized Trial of Amifostine and Carmustine-ContainingChemotherapy to Assess Lung Protective Effects.Biology of Blood and Marrow Transplantation 10:276-282 (2004). 17. Nieto Y, Vredenburgh JJ, Shpall EJ, Bearman SI, McSweeney PA, Chao N, Rizzieri D, Gasparetto C, Matthes S, Baron AE, Jones RB. Phase II feasibility and pharmacokinetic study of concurrent administration of trastuzumab and high-dose chemotherapy in advanced HER2+ breast cancer. American Association for Cancer Research volume 1, number 10, November 2004. 18.Nieto Y, Shpall EJ, Bearman SI, McSweeney PA, Cagnoni PJ, Matthes S, Gustafson D, Long M, Baron AE, Jones RB: Phase I and pharmacokinetic study of docetaxel combined with melphalan and carboplatin, with autologous hematopoetic progenitor cell support, in patients with advanced refractory malignancies. Journal of the American Society of Blood and Marrow Transplantation volume 11, number 4, April 2005. Abstracts: 1.Beck JT, Matthes S, Steenbergen C, Wormley J, Peters WP, Jones RB: Mesna prevents acute lethality and tissue injury from high dose cyclophosphamide in rats. Proc. Amer. Assoc. Cancer Res. 31:332/ 1990 2.Jones RB, Matthes S, Stemmer S, Shpall EJ: Chemical mechanism of cytotoxic induced pulmonary injury during Bone Marrow Transplantation. NIH Conference. ILD, AACR 1991 3. Matthes S, Jones RB, Dufton C, Shpall EJ, Stemmer S, Bearman SI: Extraction and pharmacokinetic analysis of BCNU in patients receiving high dose combination chemotherapy with autologous bone marrow transplantation. 34th Rocky Mountain Conference on Analytical Chemistry, Abs. 19, 1992 4. Cagnoni PJ, Stemmer SM, Matthes S, et al. High doses of taxol, cyclophosphamide and cisplatin with CD 34+ peripheral blood progenitor cell rescue. A phase I trial. Plenary Session at the First Annual Meeting of the American Society for Blood and Marrow Transplantation, Keystone, Colorado, January 26-28,1995. 5. Cagnoni PJ, Matthes S, Dufton C, et al. Ondansetron significantly reduces the area under the curve of high dose cyclophosphamide and cisplatin. Accepted for oral presentation at the Annual Meeting of the American Society of Clinical Oncology, Los Angeles, CA, 1995. 6. Cagnoni PJ, Stemmer SM, Matthes S, et al. High doses of taxol, cyclophosphamide and cisplatin with CD34+ peripheral blood progenitor cell rescue. A phase I study. American Society for Blood and Marrow Transplantation 1995: 33. 7. Cagnoni PJ, Matthes S, et al. Ondansetron significantly reduces the area under the curve (AUC) of cyclophosphamide (CPA) and cisplatin (CDDP). Proc Amer Soc Clin Oncol 14:A1489, 1995. 8. Cagnoni PJ, Stemmer SM, Matthes S, et al. Phase I trial of high dose paclitaxel (Taxol), cyclophosphamide and cisplatin with autologous hematopoietic progenitor cell (AHPC) rescue. Annual Meeting of the American Society of Clinical Oncology, Los Angeles, CA, 1995. 9. Cagnoni PJ, Shpall EJ, Matthes Set al. Paclitaxel-containing high-dose chemotherapy with autologous hematopoietic progenitor cell support (AHPCS). Anti-Cancer Treatment, Sixth International Congress, p 149, Paris, France, February 6-9, 1996. 10. Cagnoni PJ, Nieto Y, Shpall EJ, Matthes Set al. Pulmonary toxicity secondary to paclitaxel-containing high-dose chemotherapy. Proc ASCO: 16:232a (Abst 814), 1997. 11. Nieto Y, Cagnoni PJ, Bearman SI, Shpall EJ, Matthes S et al. Central nervous system (CNS) toxicity secondary to taxol-containing high-dose chemotherapy (HDC). Proc Amer Assoc Cancer Res 39:325 (Abst 2220), 1998. 12. Cagnoni PJ, Matthes S, Baron AE, Dunbar SE, Day T, Nieto Y, Jones RB. Pharmacokinetics of BCNU in melphalan pretreated Sprague-Dawley rats. Proc Amer Assn. Cancer Res 39:524(Abst 3563), 1998. 13. Cagnoni PJ, Ceriani RL, Cole W, Johnson T, Quaife R, Nieto Y, Matthes S et al. Phase I study of high-dose radioimmunotherapy with 90-Y-hu-BrE-3 followed by autologous stem cell support in patients with metastatic breast cancer. Proceedings of the 7th Conference on Radioimmunodetection and Radioimmunotherapy of Cancer, Princeton, New Jersey, 1998. 14. Cagnoni PJ, Ceriani RL, Cole W, Johnson T, Quaife R, Nieto Y, Matthes S et al. High-dose radioimmunotherapy for metastatic breast cancer with 90Y-huBrE-3: A phase I study with autologous stem-cell support. Poster Presentation at the 21st Annual San Antonio Breast Cancer Symposium, San Antonio, Texas, 1998. Breast Cancer Res Treat 50 (3): 249, 1998. 15. Cagnoni PJ, Ceriani RL, Cole W, Johnson T, Quaife R, Nieto Y, Matthes S et al. Phase I study of high-dose radioimmunotherapy with 90-Y-hu-BrE-3 with autologous stem cell support (ASCS) in patients with metastatic breast cancer. Bone Marrow Transplant 23(Suppl 1):S38, 1999. 16. Cagnoni PJ, Ceriani RL, Cole W, Johnson T, Quaife R, Nieto Y, Matthes S et al. Phase I study of high-dose radioimmunotherapy with 90-Y-hu-BrE-3 with autologous stem cell support (ASCS) in patients with metastatic breast cancer. Bone Marrow Transplant 23 (Suppl 1):S38, 1999. 17. Nieto Y, Cagnoni PJ, Shpall EJ, Bearman SI, McSweeney P, Matthes S, et al. Phase I trial of docetaxel (DTX) combined with fixed doses of melphalan and carboplatin, with peripheral blood progenitor cell (PBPC) support in refractory malignancies. Poster Presentation at the 36th Annual Meeting of the American Society of Clinical Oncology (ASCO), New Orleans, Louisiana, 2000.Proc ASCO 19: 56a (abstract # 217), 2000 18. Nieto Y, Nawaz S, Jones RB, Shpall EJ, Cagnoni P, McSweeney P, Beaudet J, Razook C, Matthes S, Bearman SI. Analysis of prognostic factors in patients with metastatic breast cancer (MBC) with no evidence of disease (NED) prospectively enrolled on a phase II trial of high-dose chemotherapy (HDC) with autologous stem-cell transplant (ASCT). Presentation at the Poster Discussion Session at the 37th Annual Meeting of the American Society of Clinical Oncology (ASCO), San Francisco, 2001.Proc ASCO 20: 8a (abstract # 30), 2001. 19.Others pending. References available upon request